New hope for advanced cancer: adding local treatment may extend life
NCT ID NCT03161522
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with esophageal or stomach cancer that has spread to 3 or fewer places in the body. It compares standard chemotherapy alone to chemotherapy plus radiation or surgery to the main tumor and those spots. The goal is to see if adding local treatment helps people live longer. About 100 adults will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2018
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology * The patient is staged with EGD and PET/CT scan. * The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization. The patient must have pathologic confirmation and or radiologically visible disease. For esophageal tumors, the maximal dimension of the primary tumor may not provide reproducible measurements for RECIST and may not be visible on CT or PET/CT at diagnosis or after induction chemotherapy. Accordingly, patients are eligible regardless of the imaging measurements of the primary tumor. Additionally, in patients with non-measurable metastases, patients are eligible if there is pathology confirming metastases from a distant site. However, biopsy of a metastatic site is not required if there are visible metastases on imaging (such as ultrasound, diagnostic CT , EUS, PET/CT). * The patient has three or less observable metastatic lesions by diagnostic scans (CT scan, PET/CT, eEndoscopic ultrasound, MRI, or bone scan). Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion). * Osseous metastases or visceral metastases will each count as one metastatic site. * Each CNS metastases will count as one metastatic site. * Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation. * Symptomatic metastatic sites may be treated with radiation or surgery prior to enrollment. * Patient ECOG of 0-2, with life expectancy of at least 6 months * Patients age \>18 yrs old but \<80 yrs old and signed informed consent * Women of child-bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents. Exclusion Criteria: * Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized. * Patients with fistula documented radiographically or by EDG/EUS, EBUS. * Patients with life expectancy less than 6 months, ECOG \>3 * Female patients who are pregnant confirmed by bHCG lab test. * Patient has history of uncontrolled angina, congestive heart failure or recent MI within 6 months. * Nursing females * Patients in poor nutritional state * Patients with: * Severely depressed bone marrow function * Potentially serious infections * Known hypersensitivity to 5-fluorouracil * Known or suspected to have a dihydropyrimidine dehydrogenase deficiency (as these patients are at a greater risk of experiencing symptoms of toxicity)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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